Physicochemical and Microbiological Stability of the Extemporaneous Sildenafil Citrate Oral Suspension
Sildenafil is a potent and selective phosphodiesterase-5 inhibitor that is effectively used in the treatment of pulmonary arterial hypertension. In several countries, hospital pharmacists prepare the drug in an extemporaneous liquid preparation as there are no liquid formulations available for pedia...
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Published in | Scientia pharmaceutica Vol. 83; no. 4; pp. 659 - 670 |
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Main Authors | , , , , |
Format | Journal Article |
Language | English |
Published |
Switzerland
MDPI AG
01.10.2015
The Austrian Journal of Pharmaceutical Sciences |
Subjects | |
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Abstract | Sildenafil is a potent and selective phosphodiesterase-5 inhibitor that is effectively used in the treatment of pulmonary arterial hypertension. In several countries, hospital pharmacists prepare the drug in an extemporaneous liquid preparation as there are no liquid formulations available for pediatric and adult uses. The purpose of this study was to evaluate the stability of an extemporaneous sildenafil citrate oral suspension for 90 days, according to the ASEAN guideline on stability studies of drug products. The results showed that the preparation was a white suspension with a sweet taste. It was a viscous and weakly acidic mixture with pseudoplastic behavior. The drug content was in the range between 99.23% and 102.23%, and the microbial examination met the general requirements throughout the study period. Therefore, the extemporaneously compounded sildenafil suspensions were physically, chemically, and microbiologically stable for at least 90 days when stored at 30° and 40°C. Furthermore, the in-use stability study showed that the preparations had acceptable attributes at least 14 days after the first-time use. This might provide an alternative option when the commercial suspension is unavailable. |
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AbstractList | Sildenafil is a potent and selective phosphodiesterase-5 inhibitor that is effectively used in the treatment of pulmonary arterial hypertension. In several countries, hospital pharmacists prepare the drug in an extemporaneous liquid preparation as there are no liquid formulations available for pediatric and adult uses. The purpose of this study was to evaluate the stability of an extemporaneous sildenafil citrate oral suspension for 90 days, according to the ASEAN guideline on stability studies of drug products. The results showed that the preparation was a white suspension with a sweet taste. It was a viscous and weakly acidic mixture with pseudoplastic behavior. The drug content was in the range between 99.23% and 102.23%, and the microbial examination met the general requirements throughout the study period. Therefore, the extemporaneously compounded sildenafil suspensions were physically, chemically, and microbiologically stable for at least 90 days when stored at 30° and 40°C. Furthermore, the in-use stability study showed that the preparations had acceptable attributes at least 14 days after the first-time use. This might provide an alternative option when the commercial suspension is unavailable. |
Author | Atipairin, Apichart Woradechakul, Chuthamas Sae Yoon, Attawadee Sae Chee, Kridsada Sawatdee, Somchai |
AuthorAffiliation | 1 School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand 2 Drug and Cosmetic Research and Development Unit, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand |
AuthorAffiliation_xml | – name: 1 School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand – name: 2 Drug and Cosmetic Research and Development Unit, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand |
Author_xml | – sequence: 1 givenname: Attawadee surname: Sae Yoon fullname: Sae Yoon, Attawadee organization: School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand; Drug and Cosmetic Research and Development Unit, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand – sequence: 2 givenname: Somchai surname: Sawatdee fullname: Sawatdee, Somchai organization: School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand; Drug and Cosmetic Research and Development Unit, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand – sequence: 3 givenname: Chuthamas surname: Woradechakul fullname: Woradechakul, Chuthamas organization: School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand – sequence: 4 givenname: Kridsada surname: Sae Chee fullname: Sae Chee, Kridsada organization: School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand – sequence: 5 givenname: Apichart surname: Atipairin fullname: Atipairin, Apichart organization: School of Pharmacy, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand; Drug and Cosmetic Research and Development Unit, Walailak University, Thasala, Nakhon Si Thammarat 80161, Thailand |
BackLink | https://www.ncbi.nlm.nih.gov/pubmed/26839846$$D View this record in MEDLINE/PubMed |
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CitedBy_id | crossref_primary_10_1007_s40005_022_00578_8 crossref_primary_10_3390_pharmaceutics15041306 crossref_primary_10_1590_s2175_97902023e23359 crossref_primary_10_1016_j_ijpharm_2022_122549 crossref_primary_10_1016_j_colsurfb_2022_113018 |
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Copyright | Copyright Österreichischer Apotheker-Verlagsgesellschaft m.b.H (Austrian Pharmacists' Publishing House) 2015 Copyright: © Sae Yoon 2015 |
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Keywords | Extemporaneous preparation Suspension Sildenafil ASEAN guideline Stability study |
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Title | Physicochemical and Microbiological Stability of the Extemporaneous Sildenafil Citrate Oral Suspension |
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